Job Description

🔍 We're Hiring: Senior Clinical Trial Manager / Associate Director, Clinical Operations

📍 San Francisco Bay Area – Hybrid (3 days onsite)

🧠 Therapeutic Focus: Neurology and/or Immunology Experience Required

We're supporting a rapidly growing biotech company in the Bay Area that’s advancing a high-impact pipeline in the neurology and immunology space. They are seeking a Senior Clinical Trial Manager or Associate Director to lead and execute pivotal clinical trials with excellence and efficiency.

This is a full-time, hybrid role based in the San Francisco Bay Area , with a requirement to be onsite 3x per week . The ideal candidate brings a proactive mindset, deep clinical operations experience, and thrives in fast-moving, cross-functional environments.

🔑 Key Responsibilities:

• Lead oversight of CROs, labs, and vendor partners to ensure delivery on timelines and budget.
• Drive the creation and execution of study documents including protocols, ICFs, CRFs , and operational plans.
• Manage IRB/regulatory submissions and support study start-up activities including site selection, initiation, and investigator meetings.
• Oversee Trial Master File (TMF) setup and maintenance.
• Coordinate investigational product supply and clinical sample logistics across sites and labs.
• Monitor study performance metrics , review clinical data, and proactively identify risks or deviations.
• Report regularly to senior leadership with trial updates and mitigation plans.

✅ Qualifications:

• 8+ years of clinical operations experience in biotech, pharma, or CRO settings.
• Strong working knowledge of GCP, ICH, and FDA regulations .
• Bachelor’s degree in a scientific discipline (Advanced degree preferred).
• Therapeutic experience in neurology or immunology strongly preferred (especially in MS ).
• Proven ability to lead cross-functional teams, multitask, and drive clinical timelines forward.
• A self-starter who communicates clearly, collaborates well, and excels in fast-paced environments.

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